New report raises questions about data that helped heart drug gain FDA approval
Ticagrelor, a heart drug sold by AstraZeneca under the names Brilinta and Brilique, first gained U.S. Food and Drug Administration (FDA) approval back in 2011 to help acute coronary syndrome (ACS) patients reduce their risk of myocardial infarction or cardiovascular death. It went on to be approved for additional indications over the years and is one of the more widely used heart drugs in the world.
However, investigators are raising serious questions about the data AstraZeneca used to gain that initial FDA approval. Why do key details reported in Circulation not line up with the original data? Why does a listed co-author of one study say they were not even a participant? Why were some patients going through up to four more blood draws than expected?
These are just some of the concerns highlighted in a new report published from The BMJ.[1]
Peter Doshi, PhD, senior editor with The BMJ and a professor with the University of Maryland School of Pharmacy, launched an in-depth investigation on this subject, reaching out to countless researchers and analyzing different datasets submitted to the FDA. This latest report represents an update from Doshi’s previous investigation from late 2024.[2]
Victor Serebruany, MD, PhD, a veteran cardiovascular researcher with Johns Hopkins University, has been watching this story unfold since the beginning, even sharing concerns with AstraZeneca officials as the clinical trials were still ongoing. He was interviewed for both of the publication's investigative reports.
“It’s been obvious for years that there is something wrong with the data,” Serebruany told Doshi. “That the FDA’s leadership could look past all these problems—on top of the many problems their own reviewers identified and are now being discovered by The BMJ—is unconscionable. We all need to know how and why that happened.”
AstraZeneca chose not to comment on the alleged inaccuracies and data concerns.
Click here to read the full investigation.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.